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Introduction <p>Since the pivotal phase&#xa0;3 randomized controlled trials (RCTs) and regulatory approval of fremanezumab, a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) for migraine prevention, several real-world evidence (RWE) studies have been conducted. In this narrative review, we highlight the complementary value of RCTs and RWE studies, by examining &gt; 6&#xa0;years of fremanezumab efficacy and effectiveness data.</p> Methods <p>Embase, MEDLINE, MEDLINE In-Process, and Cochrane databases, bibliographies, and conference materials were searched for published RCT data and RWE on efficacy and effectiveness outcomes for fremanezumab. Electronic database and conference abstract searches were limited to articles published between January 2017 and September 2023, and January 2022 and September 2023, respectively.</p> Results <p>Of 48 publications identified for inclusion, 14 reported data from 10 RCTs and 34 reported data from 23 RWE studies. RCTs were of 8–12&#xa0;weeks duration (with open-label extensions up to 52&#xa0;weeks) and generally excluded individuals receiving preventive migraine treatment at baseline, and those with previous preventive treatment failures, previous exposure to CGRP pathway mAbs, or severe comorbidities. Exceptions were the UNITE study, which included participants with migraine and major depressive disorder, and the FOCUS studies, which included those with ≥ 2 prior preventive therapies. Most RWE studies included a broader population than RCTs, and were ≥ 3&#xa0;months long, with some following participants for up to 2&#xa0;years. Across RCTs, RWE studies, and population subgroup analyses, fremanezumab was consistently associated with improvements in monthly migraine and headache days, from as early as 4&#xa0;weeks and sustained for up to 52&#xa0;weeks.</p> Conclusion <p>While RCTs and RWE studies have differing strengths and weaknesses, these evidence-generation approaches have together highlighted the potential benefit of fremanezumab for preventive migraine treatment among broad, heterogenous patient populations.</p>

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Evaluating the Complementary Nature of Randomized Controlled Trials and Real-World Evidence Using Over 5 Years of Experience with Fremanezumab: A Narrative Review

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月17日

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  • Piero Barbanti,
  • Timothy Smith,
  • Verena Ramirez Campos,
  • Alejandra Elizabeth Guevara Morel,
  • Caroline Ling,
  • Preet Bhogal,
  • Caoimhe Leonard,
  • Richard James Stark

摘要

Introduction

Since the pivotal phase 3 randomized controlled trials (RCTs) and regulatory approval of fremanezumab, a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) for migraine prevention, several real-world evidence (RWE) studies have been conducted. In this narrative review, we highlight the complementary value of RCTs and RWE studies, by examining > 6 years of fremanezumab efficacy and effectiveness data.

Methods

Embase, MEDLINE, MEDLINE In-Process, and Cochrane databases, bibliographies, and conference materials were searched for published RCT data and RWE on efficacy and effectiveness outcomes for fremanezumab. Electronic database and conference abstract searches were limited to articles published between January 2017 and September 2023, and January 2022 and September 2023, respectively.

Results

Of 48 publications identified for inclusion, 14 reported data from 10 RCTs and 34 reported data from 23 RWE studies. RCTs were of 8–12 weeks duration (with open-label extensions up to 52 weeks) and generally excluded individuals receiving preventive migraine treatment at baseline, and those with previous preventive treatment failures, previous exposure to CGRP pathway mAbs, or severe comorbidities. Exceptions were the UNITE study, which included participants with migraine and major depressive disorder, and the FOCUS studies, which included those with ≥ 2 prior preventive therapies. Most RWE studies included a broader population than RCTs, and were ≥ 3 months long, with some following participants for up to 2 years. Across RCTs, RWE studies, and population subgroup analyses, fremanezumab was consistently associated with improvements in monthly migraine and headache days, from as early as 4 weeks and sustained for up to 52 weeks.

Conclusion

While RCTs and RWE studies have differing strengths and weaknesses, these evidence-generation approaches have together highlighted the potential benefit of fremanezumab for preventive migraine treatment among broad, heterogenous patient populations.